24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: rosiglitazone-metformin fixed dose combination (Drug); metformin + glimepiride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).

Official title: Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Duration of hyperglycemia episodes over 24 hours in the 2 groups will be the main criterion to compare the two drugs using a device allowing continuous glycemic measures (CGMS).

Effect of rosiglitazone and glimepiride on the number and duration of hypoglycaemic episodes

Secondary outcome:

Number of hyperglycemic episodes Number, duration of hypoglycemic episodes Post-meal glycemias HbA1c

Post-prandial glycemia (2 hours after lunch), glycemia between 05.00pm and 07.00pm, number and time of episodes with glycemia >1,50g/l, number and time of episodes with glycemia <0.80g/l and below 0.6g/l.

% of glucose values between 0.8g/l and 1.50g/l. HbA1c (mean, % responders) FPG (mean, % responders) AEs

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females aged 40 to 80 years

- Diagnosis of type 2 diabetes mellitus for at least 6 months

- Body mass index (BMI) ≥25kg/m2

- 7%≥HbA1c ≤ 9% at visit 2

- Treatment with metformin between 1. 7g/day and 3g/day for at least 12 weeks prior to

visit 1

- Female subjects must be non-pregnant, post-menopausal, surgically sterile or using

effective contraceptive measures

- Written informed consent

Exclusion Criteria:

- Use of any oral antidiabetic drug other than metformin within 12 weeks prior to

screening

- Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with

similar chemical structure

- Subjects who have required the use of insulin for glycaemic control at any time in the

past or subject with a history of metabolic acidosis including diabetic ketoacidosis

- Subjects with clinically significant ongoing oedema or with a history of oedema in the

12 months prior to visit 1

- Subjects with a history of severe hypoglycaemia

- Anemia defined by haemoglobin concentration <11. 0g/dL for males or <10. 0g/dL for

females

- Renal disease or renal dysfunction, e. g. as suggested by serum creatinine levels

≥135µmol/L in males and ≥110µmol/L in females

- Presence of clinically significant hepatic disease (i. e. ALT, AST, total bilirubin or

alkaline phosphatase >2. 5 times the upper limit of the normal reference range)

- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent

myocardial infarction

- Subjects with chronic diseases requiring periodic or intermittent treatment with oral

or intravenous corticosteroids

- Female who are lactating, pregnant, or planning to become pregnant

- Any clinically significant abnormality identified at screening which in the judgement

of the investigator makes the subject unsuitable for inclusion in the study (e. g. physical examination, laboratory test, ECG, ...)

- Use of any investigational agent within 30 days or 5 half-lives (whichever is longer)

prior to enrolment in this study

- Active alcohol, drug or medication abuse within the last 6 months or any condition

that would indicate the likelihood of poor subject compliance

- Subjects not willing to comply with the procedures described in this protocol.

GSK Clinical Trials Call Center, Montpellier 34295, France

GSK Clinical Trials Call Center, Beziers 34500, France

GSK Clinical Trials Call Center, Montpellier 34070, France

GSK Clinical Trials Call Center, Beaucaire 30300, France

GSK Clinical Trials Call Center, Montpellier 34000, France

GSK Clinical Trials Call Center, Montpellier 34080, France

GSK Clinical Trials Call Center, Sete 34200, France

GSK Clinical Trials Call Center, Nimes 30000, France

GSK Clinical Trials Call Center, Castelnau le Lez 34170, France

GSK Clinical Trials Call Center, Saint Georges d'Orques 34680, France

GSK Clinical Trials Call Center, Villeneuve les Maguelone 34750, France

GSK Clinical Trials Call Center, Montbazin 34560, France

GSK Clinical Trials Call Center, Lagord 17140, France

GSK Clinical Trials Call Center, Poitiers 86000, France

GSK Clinical Trials Call Center, Nimes 30900, France

GSK Clinical Trials Call Center, Rouen 76100, France

GSK Clinical Trials Call Center, Toulouse 31300, France

GSK Clinical Trials Call Center, Narbonne 11100, France

GSK Clinical Trials Call Center, Cournonterral 34660, France

Starting date: November 2005
Ending date: October 2007
Last updated: March 11, 2008